Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
NCT ID: NCT06196320
Last Updated: 2025-11-26
Study Results
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Basic Information
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COMPLETED
PHASE3
452 participants
INTERVENTIONAL
2024-01-24
2025-09-22
Brief Summary
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Detailed Description
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Patients will be required to have complete or near-complete occlusion of the basilar artery on baseline computed tomography angiography (CTA)/magnetic resonance angiography (MRA), defined as 'potentially retrievable' thrombus in the basilar artery. Thrombectomy is permitted within 24 hours as part of standard care but is not mandatory.
Patients will be randomized to treatment with either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg within 4.5 hours from stroke onset) or intravenous tenecteplase (0.25mg/kg, maximum 25mg). Time of onset of symptoms is defined as described by the patient or witness; if unknown, it is considered to be the last time the patient was seen well. In patients presenting with mild (e.g. vertigo, dizziness, headache, diplopia, dysarthria) stuttering symptoms followed by sudden onset of clinical deterioration with decrease in conscious state or moderate to severe motor deficits, the time of deterioration in clinical state is taken as the estimated time of basilar artery occlusion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tenecteplase
Intravenous tenecteplase (0.25mg/kg, maximum 25mg) within 24 hours ± thrombectomy at treating clinician's discretion
Tenecteplase
Intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) within 24 hours ± thrombectomy at treating clinician's discretion
Best Practice (which may include intravenous Alteplase)
Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
Best Practice (which may include intravenous Alteplase)
Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
Interventions
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Tenecteplase
Intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) within 24 hours ± thrombectomy at treating clinician's discretion
Best Practice (which may include intravenous Alteplase)
Intravenous alteplase (0.9mg/kg) within 4.5 hours from stroke onset or standard care (no lysis) ± thrombectomy at treating clinician's discretion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients presenting with posterior circulation ischemic stroke symptoms due to near-complete or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration/coma) or the time the patient was last known to be well.
3. Presence of a basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion will be defined as 'potentially retrievable' occlusion at the basilar artery. This can be a near or complete occlusion.
4. Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
5. Local legal requirements for consent have been satisfied.
Exclusion Criteria
2. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) \<6 on non-contrast CT (NCCT) or CTA-source images or MRI diffusion weighted imaging (DWI).
3. Significant cerebellar mass effect or acute hydrocephalus.
4. Established frank hypodensity on non-contrast CT indicating subacute infarction.
5. Bilateral extensive brainstem ischemia.
6. Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).
7. Other standard contraindications to intravenous thrombolysis.
8. Contraindication to imaging with contrast agents.
9. Clinically evident pregnant women.
10. Vessel imaging showing both anterior and posterior circulation large vessel occlusion.
11. Current participation in another research drug treatment protocol.
12. Known terminal illness such that the patients would not be expected to survive a year.
13. Planned withdrawal of care or comfort care measures.
14. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Yongjun Wang
professor
Principal Investigators
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Yongjun Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Bruce Campbell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Fana Alemseged, MD, PhD
Role: STUDY_DIRECTOR
University of Melbourne
Yunyun Xiong, MD, PhD
Role: STUDY_DIRECTOR
Beijing Tiantan Hospital
Locations
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Taihe County Traditional Chinese Medicine Hospital
Fuyang, Anhui, China
Lixin County People's Hospital
Haozhou, Anhui, China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
First People's Hospital of Tianshui
Tianshui, Gansu, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Heyuan People's Hospital
Heyuan, Guangdong, China
Huazhou People's Hospital
Huazhou, Guangdong, China
Shaoguan Qujiang District People's Hospital
Shaoguan, Guangdong, China
The Second Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Second People's Hospital of Guiyang
Guiyang, Guizhou, China
Qiandongnanzhou People's Hospital
Qiandongnan, Guizhou, China
Haikou People's Hospital
Haikou, Hainan, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Qiu County People's Hospital
Handan, Hebei, China
The Second Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
Tangshan Guye Traditional Chinese Medicine Hospital
Tangshan, Hebei, China
Qinghe County People's Hospital
Xingtai, Hebei, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Hongxinglong Hospital of Beidahuang Group
Shuangyashan, Heilongjiang, China
Huaxian People's Hospital of Henan
Anyang, Henan, China
Jiaozuo Coal Industry Central Hospital
Jiaozuo, Henan, China
The First People Hospital of Lingbao
Lingbao, Henan, China
Liuyang Jili Hospital
Liuyang, Henan, China
Nanshi Hospital of Nanyang
Nanyang, Henan, China
Nanle County People's Hospital
Puyang, Henan, China
Nanle Zhongxing Hospital
Puyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Guangshan County People's Hospital
Xinyang, Henan, China
Xi County People's Hospital
Xinyang, Henan, China
Taikang Xian People's Hospital
Zhoukou, Henan, China
People's Hospital of Queshan
Zhumadian, Henan, China
Zhumadian Traditional Chinese Medicine Hospital
Zhumadian, Henan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
The Fourth People's Hospital of Chenzhou
Chenzhou, Hunan, China
Hengyang Central Hospital
Hengyang, Hunan, China
Keshketeng Banner Chinese-Mongolian Hospital
Keshketeng Banner, Inner Mongolia, China
Tongliao People's Hospital
Tongliao, Inner Mongolia, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
Jilin Electric Power Hospital
Changchun, Jilin, China
Siping City Central People's Hospital
Siping, Jilin, China
Liuhe County People's Hospital
Tonghua, Jilin, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
The Second People's Hospital of Dongying
Dongying, Shandong, China
Gaomi People's Hospital
Gaomi, Shandong, China
Laizhou City People's Hospital
Laizhou, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
The Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Weihai Central Hospital
Weihai, Shandong, China
Yantai Taochun Central Hospital
Yantai, Shandong, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Linfen Central Hospital
Linfen, Shanxi, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo Beilun District People's Hospital
Ningbo, Zhejiang, China
Beijing Daxing District People's Hospital
Beijing, , China
Countries
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References
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Xiong Y, Alemseged F, Cao Z, Schwamm LH, Parsons M, Fisher M, Wu S, Campbell BCV, Wang Y. Tenecteplase versus standard care in patients with acute basilar artery occlusion: a multi-centre, prospective, randomised, open-label, blinded endpoint, phase 3, controlled trial. Stroke Vasc Neurol. 2025 Oct 28:svn-2025-004432. doi: 10.1136/svn-2025-004432. Online ahead of print.
Other Identifiers
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CSA2023YJ002
Identifier Type: -
Identifier Source: org_study_id
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